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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038892
Receipt No. R000044266
Scientific Title Cost-effectiveness analysis of EGFR T790M mutant testing after acquired resistance to 1st/2nd generation EGFR-TKI in unresectable/recurrent non-small cell lung cancer
Date of disclosure of the study information 2019/12/15
Last modified on 2019/12/15

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Basic information
Public title Cost-effectiveness analysis of EGFR T790M mutant testing after acquired resistance to 1st/2nd generation EGFR-TKI in unresectable/recurrent non-small cell lung cancer
Acronym Cost-effectiveness analysis of EGFR T790M mutant testing after acquired resistance to 1st/2nd generation EGFR-TKI in unresectable/recurrent non-small cell lung cancer
Scientific Title Cost-effectiveness analysis of EGFR T790M mutant testing after acquired resistance to 1st/2nd generation EGFR-TKI in unresectable/recurrent non-small cell lung cancer
Scientific Title:Acronym Cost-effectiveness analysis of EGFR T790M mutant testing after acquired resistance to 1st/2nd generation EGFR-TKI in unresectable/recurrent non-small cell lung cancer
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the health economics of EGFR T790M mutant testing after acquired resistance to 1st/2nd generation EGFR-TKI in advanced/recurrent non-small cell lung cancer.
Basic objectives2 Others
Basic objectives -Others None
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ICER of EGFR T790M mutant testing
Key secondary outcomes Time to treatment failure (TTF), Overall survival (OS), Cost

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Aged 20 years or older 2) Histological or cytological proven NSCLC 3) EGFR mutation positive 4) After acquired resistance to 1st/2nd generation EGFR-TKI
Key exclusion criteria 1) patients treated with immunocheckpoint inhibitors after acquired resistance 1st/2nd generation EGFR-TKI 2) patients received at least 1 regimen of anti tumor therapy within 3 months prior to initiation of 1st/2nd generation EGFR-TKI treatment 3) complicated by haemophilia 4) complicated by leukaemia 5) complicated by severe heart failure
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Tomoyuki
Middle name
Last name Takura
Organization The University of Tokyo, Faculty of Medicine
Division name Medical Economics
Zip code 113-8655
Address 7-3-1, Hongo, Bunkyo-ku, 113-8655, Tokyo, Japan
TEL +817069363485
Email value-s@umin.ac.jp

Public contact
Name of contact person
1st name Takafumi
Middle name
Last name Hosokawa
Organization Daiichi Sankyo Co., Ltd.
Division name Medical Affairs Division
Zip code 103-8426
Address 3-5-1, Nihonbashi-honcho, Chuo-ku, Tokyo, Japan
TEL 03-6225-1111
Homepage URL
Email hosokawa.takafumi.bd@daiichisankyo.co.jp

Sponsor
Institute The University of Tokyo, Faculty of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The University of Tokyo, Faculty of Medicine, Institutional Review Board
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
Tel +81358410818
Email ethics@m.u-tokyo.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 12 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2019 Year 11 Month 05 Day
Date of IRB
2019 Year 11 Month 05 Day
Anticipated trial start date
2019 Year 11 Month 05 Day
Last follow-up date
2022 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information [Medical advisor]
Hidehito Horinouchi, Department of Thoracic Oncology, National Cancer Center Hospital

Management information
Registered date
2019 Year 12 Month 15 Day
Last modified on
2019 Year 12 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044266

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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